Summary
The Nagoya Protocol (Compliance) (Amendment) (EU Exit) Regulations 2018 amend the Nagoya Protocol (Compliance) Regulations 2015 and EU Regulation 511/2014 to adapt them for UK use post-Brexit. The regulations implement the international Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, establishing compliance measures including: a register of collections, monitoring of user compliance, best practice recognition schemes, competent authority designation, and reporting requirements. Key changes replace EU Commission references with the Secretary of State and substitute 'United Kingdom' for 'Union'.
Reason
This regulation imposes ongoing compliance costs on research institutions, biotech companies, and SMEs using genetic resources through mandatory registration, monitoring, reporting, and best-practice approval requirements. While the Nagoya Protocol's objectives (benefit sharing from genetic resources) may be valid internationally, the compliance machinery created—register maintenance, competent authority designation, user monitoring, periodic reporting every five years and review every ten years—adds bureaucratic burden with questionable marginal benefit over the underlying international obligations. The EU-derived framework was retained wholesale without democratic review and gold-plated the original international requirements. Post-Brexit regulatory independence should include reassessing whether this entire compliance regime is necessary for UK interests or whether a lighter-touch approach to meeting international obligations would serve Britain better while reducing costs on the scientific and commercial communities that work with genetic resources.